This one-day Workshop will explore the ethical and regulatory issues that pose unique challenges to planning and implementing pragmatic clinical trials. Such trials are distinct from more traditional clinical trials, as they are designed to assess the impact of interventions delivered in usual or real-world conditions. Moreover, the development of fully integrated health care systems and information technology has facilitated implementation of large-scale, cost-effective trials that leverage existing infrastructure to answer important clinical questions. Although pragmatic clinical trials provide an opportunity for generating evidence that informs decisions on both health and health care, several aspects of the current ethical and regulatory oversight of clinical research must be carefully considered.

The NIH Health Care Systems Research Collaboratory, initiated in 2012 by the NIH Common Fund, has launched a set of pragmatic clinical trials in partnership with several US health care systems. These trials have served as case studies for, among other things, navigating the current regulatory landscape for oversight of clinical research in the US. Addressing relevant ethical and regulatory issues for pragmatic clinical trials requires careful consideration of the trial population, setting, and intervention, as well as strategies for engaging relevant stakeholders in the clinical research enterprise. The Collaboratory’s Ethics and Regulatory Workgroup identified several topics relevant to pragmatic trials and published a series of manuscripts in a special issue of the journal Clinical Trials in October 2015.

The Workshop will include a series of moderated discussions on specific issues that were addressed by Collaboratory trials, such as considerations for altered informed consent, minimal risk, research oversight entities, and privacy considerations in large scale trials. Each presentation will use case examples from the Collaboratory pragmatic trials to illustrate these challenges and describe how they were addressed. The Workshop aims to inform research funders and investigators on progress with navigating ongoing ethical and regulatory challenges for pragmatic clinical trial research.

Objectives:

Describe the unique challenges pragmatic clinical trials (PCTs) face in the current ethical and regulatory environment
Provide strategies to address some of these challenges from ongoing PCTs
Identify available and needed resources to assist pragmatic clinical trial research funders and investigators to address ethical and regulatory requirements

We invite participants to submit questions or specific areas of concern during the registration process. We will attempt to address as many questions/areas of concern as possible during the workshop. Questions will also be welcomed by email during the workshop.

Agenda:

May 10, 2016 - Lister Hill Auditorium - 8:00 am – 4:30 pm

8:00 am - Welcome and Introduction

Josephine P. Briggs, MD

Director

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Catherine M. Meyers, MD, FAHA

Director, Office of Clinical & Regulatory Affairs

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Wendy Weber, ND, PhD, MPH

Chief, Clinical Research Branch, Division of Extramural Research

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

8:10 am - Keynote

Jeremy Sugarman, MD, MPH, MA

Harvey M. Meyerhoff Professor of Bioethics and Medicine

Johns Hopkins Berman Institute of Bioethics

8:30 am - Options for Altered Consent and the Importance of Minimal Risk Determination

Moderator: Kevin P. Weinfurt, PhD

Professor in Psychiatry and Behavioral Sciences

Duke University School of Medicine

Co-Director, Program for Empirical Bioethics

Duke Clinical Research Institute

Panel:

Laura M. Dember, MD

Professor of Medicine

University of Pennsylvania, School of Medicine

Gregory E. Simon, MD, MPH

Senior Scientific Investigator

Group Health Research Institute

Group Health Cooperative

John D. Lantos, MD

Director of Pediatric Bioethics

University of Missouri-Kansas City School of Medicine

Emma Meagher, MD

Senior Associate Dean for Clinical Research

University of Pennsylvania

Moderator Summary

Q&A

10:15 am - Break

10:30 am - Oversight of Pragmatic Clinical Trials – Institutional Review Boards and Data & Safety Monitoring Boards

Moderator: Adrian F. Hernandez, MD, MHS, FAHA

Professor of Medicine

Duke University School of Medicine

Director, Outcomes & Health Services Research

Faculty Associate Director

Duke Clinical Research Institute

Panel:

Douglas F. Zatzick, MD

Professor and Vice Chair for Health Services

University of Washington School of Medicine

Harborview Medical Center

Pearl O’Rourke, MD

Director, Human Research Affairs

Director, ESCRO

Partners HealthCare

Susan S. Ellenberg , Ph.D.

Professor of Biostatistics and Epidemiology

University of Pennsylvania Perelman School of Medicine

Moderator Summary

Q&A

12:15 pm - Lunch

1:15 pm - Privacy Issues for Pragmatic Clinical Trials

Moderator:Valerie Bonham, J.D.

Senior Attorney

Office of the General Counsel

Public Health Division

National Institutes of Health, DHHS

Sarah M. Greene, MPH

Executive Director

Health Care Systems Research Network

Valery Gordon, Ph.D., M.P.H.

Director, Clinical Research Policy

Office of Science Policy

National Institutes of Health, DHHS

Miguel Vazquez, MD

Medical Director of Kidney Transplantation

Professor, Internal Medicine

University of Texas Southwestern Medical Center

Moderator Summary

Q&A

2:00 pm - Vulnerable Populations

Moderator:David Wendler, PhD

Senior Researcher

NIH Clinical Center

National Institutes of Health, DHHS

Panel:

Susan S. Huang, MD, MPH

Professor, Infectious Disease

Medical Director, Epidemiology and Infection Prevention

School of Medicine

University of California, Irvine

Mary Jane Welch, DNP, APRN, BC, CIP

Assistant Professor

Community Systems and Mental Health Nursing

Director, Human Subjects’ Protection

College of Nursing

Rush University Medical Center

Moderator Summary

Q&A

2:45 pm - Break

3:00 pm - Expert Panel Q&A

Expert Panel Q&A

Moderator:Jeremy Sugarman, MD, MPH, MA

Harvey M. Meyerhoff Professor of Bioethics and Medicine

Johns Hopkins Berman Institute of Bioethics

Panel:

Kevin P. Weinfurt, PhD

Professor in Psychiatry and Behavioral Sciences

Duke University School of Medicine

Co-Director, Program for Empirical Bioethics

Duke Clinical Research Institute

Adrian F. Hernandez, MD, MHS, FAHA

Professor of Medicine

Duke University School of Medicine

Director, Outcomes & Health Services Research

Faculty Associate Director

Duke Clinical Research Institute

Valerie Bonham, J.D.

Senior Attorney

Office of the General Counsel

Public Health Division

National Institutes of Health, DHHS

David Wendler, PhD

Senior Researcher

NIH Clinical Center

National Institutes of Health, DHHS

4:00 pm - Concluding Remarks

Concluding Remarks

Michael S. Lauer, MD, FACC, FAHA

Deputy Director for Extramural Research

Office of the Director

National Institutes of Health, DHHS

General Lister Hill Center Information

All NIH visitor information, including Parking, Driving Directions, Maps, and Security information, can be found at http://www.nih.gov/about/visitor/index.htm
Wireless Internet Access -- The building has wireless access.
Cafeteria -- On Level B-1. Located down the stairs in the center of the lobby and to the left. http://www.ors.od.nih.gov/pes/dats/food/dining/Pages/Building-38A.aspx
Coat Room — The coat room is directly outside the auditorium. Luggage may be stored in the coat room but NLM is not responsible for missing or stolen items.
Rest rooms and a water fountain are located next to the elevators. There are additional restrooms on each floor of the LHC building.

Registrations are closed

Ethical & Regulatory Issues of Pragmatic Clinical Trials Workshop